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The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance. (MORPHEUS)

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ruxolitinib cream
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring ruoltitinib, atopic dermatitis, sleep distubance, itch, Opzelura

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria. Has at least a 2-year history of AD (information obtained from medical chart, participant's physician, or directly from the participant). Has an overall BSA affected by AD of 3%-20% (excluding scalp) at the screening and baseline visits. Has an IGA score ≥ 2 at the screening and baseline visits. Has an Itch NRS score ≥ 4 at the screening and baseline visits. Willing to complete the once-daily Itch NRS (24-hour recall period) entries at approximately the same time each day during the study. Agrees to maintain a regular sleep schedule during the study period. Willing and able to follow required study procedures for measuring sleep for the duration of the study. Exclusion Criteria: Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study. Currently has a schedule that includes nighttime work shifts. Has had significant flares or unstable course in AD (ie, condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening (information obtained from medical chart, participant's physician, or directly from the participant). Has received any ultraviolet B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to the screening period. Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period. Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study. Has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the screening period. Has had prior treatment with a JAK inhibitor that was discontinued for safety reasons or tolerance problems. Has a known or suspected allergy to ruxolitinib or any component of the study drug.

Sites / Locations

  • First Oc DermatologyRecruiting
  • Ark Clinical ResearchRecruiting
  • The Gw Medical Faculty AssociatesRecruiting
  • Skin Care Research, LlcRecruiting
  • Trueblue Clinical ResearchRecruiting
  • Driven Research LlcRecruiting
  • University of Florida Health Dermatology-SpringhillRecruiting
  • Skin Care Research, Llc Scr HollywoodRecruiting
  • Ciocca Dermatology PaRecruiting
  • Dermatology Specialists Research IndianaRecruiting
  • Dawes Fretzin Clinical Research Group LlcRecruiting
  • Skin Sciences PllcRecruiting
  • Northeast Dermatology AssociatesRecruiting
  • Beth Israel Deaconess Medical Center (Bidmc)Recruiting
  • Essential DermatologyRecruiting
  • Washington University School of Medicine DermatologyRecruiting
  • Suny Downstate Health Sciences UniversityRecruiting
  • Empire DermatologyRecruiting
  • Sadick DermatologyRecruiting
  • Skin Search of RochesterRecruiting
  • Ohio Pediatric Research AssociationRecruiting
  • Oregon Dermatology and Research CenterRecruiting
  • Knight Cancer Institute At Oregon Health and Science UniversityRecruiting
  • University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical BuildingRecruiting
  • Clinical Research Center of the CarolinasRecruiting
  • Arlington Research CenterRecruiting
  • Jordan Valley Dermatology CenterRecruiting
  • Pi Coor Clinical Research Llc
  • Clinical Research Partners Llc
  • Dermatology Specialists of SpokaneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group: Ruxolitinib

Arm Description

ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.

Outcomes

Primary Outcome Measures

Change from baseline in Total Sleep Time (TST)
Total sleep time (TST) is the total amount of time spent during a planned sleep episode. TST will be measured by the Ōura Ring wearable device.

Secondary Outcome Measures

Change from baseline in PROMIS Sleep Disturbance
PROMIS sleep disturbance will be measured by a questionnaire which includes a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.

Full Information

First Posted
January 13, 2023
Last Updated
October 18, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05696392
Brief Title
The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.
Acronym
MORPHEUS
Official Title
An Open-Label, Single-Arm, Phase 4 Study of Ruxolitinib Cream in Adults With Atopic Dermatitis Experiencing Sleep Disturbance in the United States (MORPHEUS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
ruoltitinib, atopic dermatitis, sleep distubance, itch, Opzelura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group: Ruxolitinib
Arm Type
Experimental
Arm Description
ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.
Intervention Type
Drug
Intervention Name(s)
ruxolitinib cream
Other Intervention Name(s)
INCB018424
Intervention Description
ruxolitinib cream 1.5% will be applied twice daily as a thin film
Primary Outcome Measure Information:
Title
Change from baseline in Total Sleep Time (TST)
Description
Total sleep time (TST) is the total amount of time spent during a planned sleep episode. TST will be measured by the Ōura Ring wearable device.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change from baseline in PROMIS Sleep Disturbance
Description
PROMIS sleep disturbance will be measured by a questionnaire which includes a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria. Has at least a 2-year history of AD (information obtained from medical chart, participant's physician, or directly from the participant). Has an overall BSA affected by AD of 3%-20% (excluding scalp) at the screening and baseline visits. Has an IGA score ≥ 2 at the screening and baseline visits. Has an Itch NRS score ≥ 4 at the screening and baseline visits. Willing to complete the once-daily Itch NRS (24-hour recall period) entries at approximately the same time each day during the study. Agrees to maintain a regular sleep schedule during the study period. Willing and able to follow required study procedures for measuring sleep for the duration of the study. Exclusion Criteria: Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study. Currently has a schedule that includes nighttime work shifts. Has had significant flares or unstable course in AD (ie, condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening (information obtained from medical chart, participant's physician, or directly from the participant). Has received any ultraviolet B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to the screening period. Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period. Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study. Has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the screening period. Has had prior treatment with a JAK inhibitor that was discontinued for safety reasons or tolerance problems. Has a known or suspected allergy to ruxolitinib or any component of the study drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Facility Information:
Facility Name
First Oc Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Ark Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Individual Site Status
Recruiting
Facility Name
The Gw Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Care Research, Llc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Trueblue Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Driven Research Llc
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida Health Dermatology-Springhill
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Care Research, Llc Scr Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Ciocca Dermatology Pa
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Specialists Research Indiana
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Individual Site Status
Recruiting
Facility Name
Dawes Fretzin Clinical Research Group Llc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Sciences Pllc
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Name
Northeast Dermatology Associates
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center (Bidmc)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Essential Dermatology
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760?
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Suny Downstate Health Sciences University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Name
Empire Dermatology
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Name
Sadick Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Search of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio Pediatric Research Association
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
Knight Cancer Institute At Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Recruiting
Facility Name
Arlington Research Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Recruiting
Facility Name
Jordan Valley Dermatology Center
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Individual Site Status
Recruiting
Facility Name
Pi Coor Clinical Research Llc
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research Partners Llc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Completed
Facility Name
Dermatology Specialists of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency.
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.

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